[18F]F-FAPI PET/CT and LAparoscopy in STagIng advanced gastric Cancer: a multicenter prospective study (PLASTIC-3 study).
Lianne Triemstra, Sarah W J M Spruijt, Dennis Vriens...
https://pubmed.ncbi.nlm.nih.gov/41299326Actively Recruiting
Phase 2
Phase 3
Age: 18Years +
All Genders
ID07018661
[18F]F-FAPI PET/CT and Laparoscopy in Staging Advanced Gastric Cancer - a Multicenter Prospective Study
Led by Leiden University Medical Center · Updated on 2025-08-27
250
Participants Needed
10
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying a new type of scan called FAPI-PET/CT to see how well it detects metastases in patients with advanced gastric cancer. The study aims to find out if this scan can better identify cancer spread, leading to changes in treatment plans such as avoiding unnecessary surgeries or shifting to comfort-focused care. It also evaluates whether the scan causes less burden for patients compared to current methods. Participants will receive the standard care for gastric cancer and undergo one additional FAPI-PET/CT scan, where a small amount of [18F]-FAPI-74 is given intravenously about 60 minutes before a PET/CT scan lasting around 20 minutes. The results from this scan will help doctors decide on further tests or surgery needed. The study monitors changes in diagnosis and treatment decisions based on the scan. During the study, participants will complete questionnaires taking about 4 hours total and spend approximately 2 hours for the extra scan. Researchers will measure outcomes such as changes in treatment intent, diagnostic work-up, scan accuracy, incidental findings, patient burden, quality of life, and safety over about one year. Follow-up includes quality of life assessments and cost evaluations at multiple time points after staging.
CONDITIONS
Brief Title
[18F]F-FAPI PET/CT and Laparoscopy in Staging Advanced Gastric Cancer
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Histologically confirmed adenocarcinoma of the stomach or esophagogastric junction (Siewert type III) by gastroscopy
- Age 18 years or older
- Surgically resectable advanced tumor (cT3-4b, N0-3, M0) based on gastroscopy and contrast-enhanced CT of thorax and abdomen
- Intention to perform gastrectomy based on multidisciplinary team decision
- Written informed consent given
- If recently in another drug study, no likely interaction with current study procedures as judged by study team
You will not qualify if you...
- Siewert type I-II esophagogastric junction tumor
- Unfit or unwilling to undergo study procedures
- Unfit or unwilling to undergo surgery
- Pregnancy at time of PET/CT scan due to radiation exposure
- Incapacitated and unable to provide informed consent
- Medical or psychiatric conditions preventing informed consent
- Illiteracy preventing completion of questionnaires
- Inability to undergo PET/CT scan due to claustrophobia, weight limits, or inability to lie flat for about 30 minutes
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Approximately 1 to 2 weeks
Participants undergo [18F]-FAPI-74 administration followed by PET/CT scanning to detect gastric cancer metastases, followed by additional diagnostics including staging laparoscopy if necessary.
1 visit for PET/CT scanning and 1 additional diagnostic laparoscopy visit if indicated
Long-term Monitoring
Duration - Up to 12 months
Participants are monitored after diagnostic evaluation for changes in treatment intent, health-related quality of life, and impact of incidental findings.
Visits at 3, 6, 9, and 12 months after diagnostic evaluation
Trial Site Locations
Total: 10 locations
1
ZGT
Almelo, Netherlands
Not Yet Recruiting
2
Amsterdam UMC
Amsterdam, Netherlands
Not Yet Recruiting
3
Netherlands Cancer Institute - Antoni van Leeuwenhoek
Amsterdam, Netherlands
Not Yet Recruiting
4
Rijnstate
Arnhem, Netherlands
Not Yet Recruiting
5
Catharina Ziekenhuis
Eindhoven, Netherlands
Not Yet Recruiting
6
Zuyderland
Geleen, Netherlands
Not Yet Recruiting
7
UMC Groningen
Groningen, Netherlands
Not Yet Recruiting
8
Leids Universitair Medisch Centrum
Leiden, Netherlands
Actively Recruiting
9
Erasmus MC
Rotterdam, Netherlands
Not Yet Recruiting
10
UMC Utrecht
Utrecht, Netherlands
Not Yet Recruiting
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Research Team
S
Sarah Spruijt, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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